“...this study included measures that allow us to demonstrate that as the symptoms of ADHD get better, there is a marked improvement in the overall functioning of children and their families--that is, when ADHD is effectively treated, it has a wide, beneficial impact on the child with ADHD as well as on the child's family”

I think there is a combination of factors involved. Perhaps most importantly is that for many years there was only one class of approved pharmacologic therapies for ADHD, the stimulants. Stimulants are effective, widely used treatments, but it always important to have different options and treatments that work by different mechanisms. There was, as a result, considerable interest and anticipation in the physician and patient communities of atomoxetine as a new, non-stimulant alternative. As atomoxetine was being developed, this interest and awareness grew rapidly, and people wanted to know more about what atomoxetine is and how well it works. This paper was the first report of a large, placebo-controlled study of atomoxetine to be published, and prior to atomoxetine's approval, it provided physicians and patients with an initial picture of what was likely to become available in the near future. I believe that it continues to be referenced because, following the approval of atomoxetine by the FDA and subsequently by regulatory authorities in other countries, clinicians and patients have looked to this paper to provide evidence-based information about how to dose atomoxetine and what kind of clinical response to expect.

This paper is important for several reasons. It provides rigorous, placebo-controlled evidence that atomoxetine is a highly effective treatment for ADHD. It provides evidence of the relationship between the dose of atomoxetine and the degree of clinical improvement, which in turn provides the key information about how to dose atomoxetine in a way that optimizes the potential benefit to patients. It also provides evidence of the safety of atomoxetine in large groups of children and adolescents. Finally, this study included measures that allow us to demonstrate that, as the symptoms of ADHD get better, there is a marked improvement in the overall functioning of children and their families—that is, when ADHD is effectively treated, it has a wide, beneficial impact on the child with ADHD as well as on the child's family.

I was trained as a research psychiatrist at Yale and at the NIMH, and came to Lilly Research Laboratories to work in developing new drugs for neuropsychiatric disorders. In 1999 I became the medical director responsible for the clinical development of atomoxetine, and this study, designed to characterize the dosage response to atomoxetine, was one of the first studies for which I was responsible.